CYBERDERM SIMPLY ZINC ULTRA (ZINC OXIDE) LOTION [CYBERDERM LABORATORIES INC.]

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CYBERDERM SIMPLY ZINC ULTRA (ZINC OXIDE) LOTION [CYBERDERM LABORATORIES INC.]
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NDC 71644-003-50, 71644-003-80
Set ID 69085599-01a5-1c83-e053-2991aa0a3432
Category HUMAN OTC DRUG LABEL
Packager Cyberderm Laboratories Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Zinc oxide* 25%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally to face and body 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:

    • Limit time in the sun, especially from 10 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
  • INACTIVE INGREDIENT

    Inactive ingredients caprylic/capric triglyceride*, coco-caprylate/caprate*, polyglyceryl-3 polyricinoleate*, isostearic acid*, polylactic acid*, coconut alkanes*, sodium-phospho-magnesium silicate, carthamus tinctorius (safflower) oleosomes*, water/eau, picea abies extract, propanediol*, titanium dioxide, stearic acid, alumina, cerium dioxide, silica, aluminum hydroxide, polyhydroxystearic acid, May contain black, yellow, red iron oxides (CI 77499, CI 77492, CI 77491), phytic acid, sodium hydroxide.

  • QUESTIONS

    Questions or comments?

    718-481-2628 Monday - Friday 9 am - 5 pm

  • SPL UNCLASSIFIED SECTION

    *Denotes ingredients that are Ecocert® certified organic.

    Distributed by:

    CyberDERM Laboratories Inc.

    650-1600 Carling Avenue

    Ottawa, ON K1Z 1G3 Canada

    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    cyberderm

    made with love by the sunscreen company™

    Simply Zinc Ultra

    Transparent sunscreen lotion

    made with 25% zinc oxide with Certified Organic Bio UVA

    Ultra and Sheer Illuminating Tint

    UVA/UVB Broad Spectrum SPF 50

    helps prevent sunburn

    50 mL (1.7 fl oz)

    Simply Zinc 50 mL

  • INGREDIENTS AND APPEARANCE
    CYBERDERM  SIMPLY ZINC ULTRA
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71644-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    PICEA ABIES FLOWER BUD (UNII: WQZ50FAU2B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CERIC OXIDE (UNII: 619G5K328Y)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    POLYLACTIDE (UNII: 459TN2L5F5)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71644-003-501 in 1 CARTON03/30/2018
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:71644-003-801 in 1 CARTON03/30/2018
    280 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:71644-003-011 in 1 CARTON06/17/2020
    3100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/30/2018
    Labeler - Cyberderm Laboratories Inc. (242524267)
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